CooperVision, the contact lens manufacturer, has recalled more than five million contact lenses that were contaminated with harmful silicon oil residue. Some people have experienced serious eye injury, including vision loss, necessitating emergency medical treatment.

What is the problem?

CooperVision, the company that creates, markets, and sells several types of contact lenses, has recently been forced to recall more than five million products. The contact lenses are used by millions of people to correct eye problems, such as myopia (nearsighedness), hyperopia (farsightedness), and astigmatism.

Consumers came to the company with complaints that they had suffered eye injuries after using the products, which prompted an investigation. The lenses were found to be contaminated with a silicon oil residue that can irritate and harm the eye. Some users complained of hazy vision, blurry vision, temporary eye pain. Some people had far more serious reactions to the silicon oil reside, however, including vision loss.

If you are using Avaira Sphere or Avaira Toric contact lenses and you experience a serious side effect, you should go to the emergency room to receive treatment. You may have been exposed to a harmful substance.

Class 1 FDA Recall

The CooperVision Avaira Sphere and Avaira Toric products are under a Class 1 Food and Drug Administration Recall, which is the highest recall level, saved for products that may cause serious harm to consumers.

To give you an idea of how serious this recall is, other examples of Class 1 FDA recalls are: widespread label mix-ups on prescription drugs, food that has been contaminated with deadly bacterial pathogens, and artificial heart valves that are defective.

What contact lenses are affected?

CooperVision has voluntarily recalled Avaira Sphere and Avaira Toric contact lenses manufactured from February 1, 2011 through August 24, 2011. You may have purchased these products between March 2, 2011 through November 15, 2011.

History of the Recall

CooperVision first recalled its products in August of 2011, following reports of consumer injuries. The recall was small, and involved only a few lots of Avaira Toric contact lenses. Subsequent tests, however, showed that far more products were contaminated with the silicon oil residue than previously thought. On November 16, 2011, the company expanded the recall to include more than 600,000 products, including the Avaira Sphere contact lenses. Though the recall was far larger, it was not the end. On December 7, 2011, CooperVision dramatically expanded the recall again — this time, to include more than five million lots of Avaira Sphere and Avaira Toric contact lenses. Some people who have used these lenses have experienced severe eye injuries.

I use Avaira Sphere contact lenses. What can I do?

Stop wearing your contacts — they may be contaminated.

Do not throw away the contacts or the box they came in. Put them in a safe place, because you are going to need the lot number printed on the box.

Especially if you have been injured, contact your eye doctor and tell them you have contacts that are part of a massive recall, and you have been injured by the product. The FDA collects this information to better protect and inform the public about dangerous medical devices. If you prefer, you can call the FDA hotline yourself at: 1-800-332-1088.

What is Astigmatism?

Optometrists have prescribed CooperVision contacts to millions of Americans for the treatment of astigmatism. This is a type of vision problem that affects the cornea, which is the clear tissue covering the front of the eye. People with astigmatism have a cornea that is curved in a way that makes it difficult for the eye to focus light. The result is blurry vision, close up and also far away. The person may also experience eye discomfort, headaches, and other symptoms in the most serious cases.

What is myopia (nearsightedness) and hyperopia (farsightedness)?

Optometrists have also prescribed CooperVision contacts to millions of Americans for the correction of nearsightedness and farsightedness.

Myopia, or “nearsightedness,” occurs when a person can focus clearly on objects that are close, but objects that are far away appear blurry. Like astigmatism, it occurs because a part of the eye is misshapen, and so light entering the eye is focused incorrectly. As a person ages, myopia often gets worse, but there are many options for treatment. Contact lenses, glasses, and LASIK surgery can usually mitigate the symptoms of myopia.

Hyperopia, or “farsightedness,” occurs when a person can focus clearly on objects that are far away, but not close up. It most frequently manifests as a difficulty reading and writing, which can be particularly serious if it is not diagnosed early in children, because they have difficulty learning. Hyperopia is treatable with contacts and glasses.

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